.Patient Blood Management Program in Liver Transplantation

NCT05187637 | Unknown DMC FDA Drug

• 1 other identifier: EOM025/21
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Transfusion management improvement programs, generally known as patient blood management (PBM) programs, are based on a set of perioperative measures aimed at improving clinical outcomes by avoiding unnecessary exposure to blood components. In a recent series of liver transplants (LT) performed in Spanish centers belonging to the Spanish Liver Transplant Society, despite optimal hemostasis management and preservation of the vena cava, around 20% of patients required massive transfusion (considered as the administration of 6 or more red blood cell concentrates intraoperatively). In addition, 63% of the patients were transfused with at least one packed red cells during the operation. By correcting the iron deficiency in patients who meet the criteria of the anemia study (transferrin saturation less than 20%), we could improve the hemoglobin level, which would allow a wider margin for the transfusion of red cell concentrates.

Conditions

Iron Deficiency Anemia

Keywords

iron deficiency; liver transplantation; intravenous iron

Outcome Measures

Primary Outcomes (1)

• degree of implementation of the PBM programme

  To assess the degree of implementation of the PBM Programme in its first pillar in patients with iron deficiency anaemia, determining the degree and quality of implementation of the PBM programme in liver transplantation, measured as the percentage of patients complying with the iron correction protocol

  30 days after the intervention or pre-surgery

Secondary Outcomes (2)

• Effectiveness

  Pre-surgery

• Clinical efficacy

  immediately after the surgery

Other Outcomes (1)

• security

  immediately after the intervention

Study Arms (2)

Intervention

Patients on the waiting list for liver transplantation with haemoglobin less than 11.5g/dL and transferrin saturation index less than 40% with ferritin less than 800mcg/L, which are considered iron deficiency susceptible to respond to intravenous iron administration.

Drug: intravenous iron

Control

Patients on the waiting list for liver transplantation in the same period of the intervention cohort, with haemoglobin less than 11.5g/dL and transferrin saturation index more than 40%, which are considered of non susceptibles for iron supplement alone.

Interventions

intravenous iron DRUG

One dose of intravenous iron carboxymaltose calculated according to ganzoni's formula. If after thirty days of the first dose, a second dose of 500mg will be administered if the patient continues to meet the inclusion criteria.

Also known as: ferinject

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis of the liver on the waiting list for liver transplantation

You may qualify if:

• liver cirrhosis on the liver transplant waiting list
• haemoglobin lower than 11.5g/dL
• transferrin saturation index below 40%
• ferritin below 800mcg/L

You may not qualify if:

• refusal to participate
• Known hypersensitivity to Ferinject
• current infection

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• University of Barcelona: collaborator

Study Sites (1)

HUBellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Annabel MJ Blasi, MD, PhD

  Hospital Clinic Universitary

  STUDY DIRECTOR

Central Study Contacts

Antoni Sabate, MD

CONTACT

+346300836544; asabatep@bellvitgehospital.cat

Lourdes LP Perez, MD,PhD

CONTACT

+346300836544; lourdes.perez@bellvitgehospital.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 12, 2022
• Study Start: March 23, 2022
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

ES (1)